FDA Policy/General
Federal Register notice: FDA has announced a public workshop entitled “Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design.” The agency says that complex and innovative trial designs have the potential to optimize drug development in small populations. Innovations that have been proposed include Bayesian and other methods of
Devices
In a detailed report, the investigative newsroom Pro Publica says FDA relies too much on medical device manufacturers to correct problems with their products and takes too little action to ensure compliance. The report focuses primarily on the HeartWare ventricular assist device (HVAD) used as a heart pump while a
Devices
FDA has approved a Pillar Biosciences PMA for its oncoReveal Dx Lung and Colon Cancer Assay, a next-generation sequencing (NGS) tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal cancer tumors. Pillar says the
Drugs
Based on data from the Phase 3 KEYNOTE-716 trial of Merck’s Keytruda (pembrolizumab), FDA has accepted the company’s sBLA for the adjuvant treatment of adults and children age 12 and older with stage 2B or 2C melanoma following complete resection. The agency says it will give the
Devices
FDA says an Eight Medical 2/5/21 recall of specific lots of its Recirculator 8.0 disposable lavage kit was Class 1. The company recalled 288 devices in the U.S. An FDA recall notice says the kit is used with the company’s hyperthermic perfusion system. It allows
Devices
Eco-Med Pharmaceuticals has recalled certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination. Affected products are also distributed as MediChoice Ultrasound Gel by Owens and Minor and Mac Medical Supply. The gels are non-sterile and not indicated for sterile procedures, the company says. The
Drugs
The HHS Office of Inspector General (OIG) says its report assessing how FDA implements the accelerated approval pathway is expected to be issued in 2023. In an online notice, the OIG says FDA’s recent approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s patients “raised concerns due to
FDA Policy/General
A Spherix Global Insights survey of 252 specialists in dermatology, gastroenterology, nephrology, neurology, and rheumatology found that confidence in FDA is swiftly diminishing. The survey says only 36% of respondents expressed a high level of assurance in the agency, with nearly one-half saying their confidence in FDA has eroded
Drugs
An FDA complete response letter to Medexus Pharma and its medac licensor says the agency can’t approve their NDA for treosulfan in its present form. The NDA was submitted for treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation. The FDA letter provided
Devices
FDA has cleared a Camber Spine 510(k) for both its Spira-P Posterior Lumbar Spacer technology and Spira-T Oblique Posterior Lumbar Spacer technologies. The clearance covers their use in skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2-S1.The devices are
Drugs
The 14 life science companies that belong to the Rare Disease Company Coalition (RDCC) have written to House and Senate leaders to express their support for the FDA accelerated approval program. Their 7/29 letter also discusses concerns with policy recommendations from the Medicaid and CHIP Payment Access Commission (MACPAC)
Devices
BD says it will begin remediation for the 2/4/20 BD Alaris system 1 recall through a new version of software. The recall notified customers of several conditions under which the Alaris infusion pump may not operate as expected. BD says the new software is expected to remediate the
FDA Policy/General
Federal Register notice: FDA is updating its listing of Emergency Use Authorizations (EUAs) for use during the Covid-19 pandemic. It has been updated to reflect a 5/26 EUA for GlaxoSmithKline’s sotrovimab, and a 6/24 EUA for Genentech’s Actemra (tocilizumab). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that Novartis’ Votrient (pazopanib hydrochloride) tablets, 400 mg, were not withdrawn from sale due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Votrient is a kinase
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 6/24 notice on a draft guidance entitled Remanufacturing of Medical Devices. Comments can now be submitted until 9/22. The guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.” The document says such
Devices
FDA says it is participating in several new collaborative communities intended to address challenges in patient health care. An online notice says the communities are a continuing forum where private and public sector representatives of the community work together on medical device challenges to achieve common objectives and outcomes. The
Drugs
FDA’s orphan designation is based on data from the university that suggest ketamine has the potential to increase life expectancy of ALS patients at any stage and slow the progressive loss of muscle associated with poor outcomes, PharmaTher says. “Ketamine works by blocking the action of the ionotropic glutamate
Biologics
The Bloomberg editorial board says FDA is undermining its credibility by not speaking out forcefully and completely as calls increase for full approval of the Covid-19 vaccines that have been granted emergency use authorizations. In an online post, the editorial board says FDA insists it is “working as quickly
Drugs
FDA has released the FDA-483 issued following a 2/18-3/16 inspection at the Eli Lilly sterile drug manufacturing facility in Indianapolis, IN. The seven inspection observations were: * failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas; * failing to thoroughly investigate any unexplained
Devices
FDA has posted a Web page that responds to common questions on online 506J notification submission methods concerning medical device manufacturing interruptions, including the Web form and spreadsheet template. The page covers submissions under section 506J of the Federal Food, Drug, and Cosmetic Act during the Covid-19 pandemic. The
Devices
Arriva Medical, at one time the nation’s largest mail-order diabetic testing supplier, and its Alere parent will pay $160 million to resolve allegations they violated the False Claims Act. A Justice Department news release says Arriva ceased business operations 12/2017. It was acquired by Alere in 2011.
Drugs
Bristol Myers Squibb has announced its decision to withdraw a 2011 indication granted to subsidiary Celgene under accelerated approval for Istodax (romidepsin), a histone deacetylase inhibitor, as monotherapy for treating peripheral T-cell lymphoma in adult patients who have received at least one prior therapy. This accelerated approval was based